Specialized Trial Manager

SThree • Contract • Boston, MA, US • $90,000 - $140,000 / year • 2w ago

Clinical trials represent some of the most rigorous work in healthcare, where precision, compliance and patient safety form the foundation of every decision. A Specialized Trial Manager guides these complex programs through their lifecycles, ensuring protocols are followed, data integrity is maintained, and regulatory requirements are met at every stage. This is an opportunity to register your interest in future Specialized Trial Manager roles within clinical research environments where your expertise could directly support the advancement of treatments and the protection of patient welfare.

Please note the content of this advert does not represent a live vacancy.

About the opportunity

Roles of this type sit within clinical research organizations, contract research organizations (CROs), or sponsor companies managing Phase I through Phase IV trials. The environment is typically collaborative and detail-oriented, with regular interaction across clinical, regulatory, quality and operations teams. You would be expected to manage trial protocols from initiation through closeout, coordinate with investigator sites, ensure compliance with Good Clinical Practice (GCP) and regulatory frameworks, and support the integrity of trial data and patient safety reporting. The role could offer scope to mentor junior staff and shape how trials are executed within your organization.

Typical role overview

Location: Boston, Massachusetts, USA
Type: Permanent · Full-time
Salary: $90,000 - $140,000 per annum
Domain: Clinical research · Regulated trials · Life sciences

What you would do

Typical responsibilities could include:

Managing end-to-end trial protocol execution, from site initiation through database lock and closeout
Coordinating investigator sites, including onboarding, training, monitoring visits and issue resolution
Ensuring compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and applicable regulatory requirements
Maintaining trial documentation, regulatory files and audit trails in accordance with company standards and regulatory expectations
Preparing and reviewing trial reports, safety summaries and regulatory submissions
Supporting patient safety monitoring, including adverse event reporting and safety signal review
Collaborating with clinical, quality, regulatory and data teams to maintain protocol compliance and data integrity
Mentoring and providing guidance to junior trial coordinators or team members where applicable

What you could bring

Most roles of this type require the following:

Must-have

10-15 years of clinical trial management, clinical research coordination, or related clinical operations experience
Working knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines
Experience managing Phase I, II, III or IV trials in a sponsor or CRO environment
Strong understanding of regulatory requirements, including FDA and ICH compliance frameworks
Proficiency with electronic data capture (EDC) systems, trial management systems and standard office software
Bachelor's degree in Life Sciences, Biology, Chemistry or a related field
Certification such as ACRP (Association of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) preferred
Authorization to work in the United States

Nice-to-have

Master's degree in Clinical Research, Regulatory Affairs or a related discipline
Experience with multi-center or international trials
Familiarity with data integrity audits and regulatory inspections
Project management certification (PMP or equivalent)

What roles of this type could offer

Most roles of this type offer the following, dependent on the industry and seniority of the role:

Meaningful involvement in clinical research that could advance patient treatments and safety
Scope to develop expertise in trial management and regulatory compliance
Potential for progression toward senior or lead trial management roles
Collaborative work environment with clinical, regulatory and operations professionals
Professional development through continuing education and certification support
Competitive benefits including health, dental and vision coverage, paid time off, 401(k) contributions and flexible work arrangements where supported by the role
Structured opportunities to mentor and guide junior team members

About Specialist Staffing Group

Specialist Staffing Group partners with leading healthcare, life sciences and clinical research organizations to identify, assess and place experienced professionals in roles where regulatory knowledge, clinical expertise and attention to detail drive patient safety and trial success. We understand the specialized nature of clinical trial management and work to match professionals with opportunities where their compliance background, organizational skills and stakeholder management experience create measurable impact.

How to register interest

If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career.

Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.